Manufacturer registered with FDA
Henan Dian Tong Dental Material Co.,Ltd.
Anyang, China. Lists 1 dental device type with FDA across 0 registered establishments.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 34 registrations outside the US
- Establishments
- 0—
Registered in 3 markets
Where regulators' registries name Henan Dian Tong Dental Material Co.,Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Henan Dian Tong Dental Material Co.,Ltd. | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Henan Dian Tong Dental Material Co, LtdHenan Dian Tong Dental Material | 3 | 2024–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Henan Dian Tong Dental Material Co Ltd | 1 | 2026–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Henan Dian Tong Dental Material Co.,Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental burs | 2026 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10096689). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.